‘Ludicrous mandated confusion’

It's anybody's guess which will arrive first: the golden anniversary of what some call the 'ludicrous,' 'absurd,' 'bizarre' and 'severely restrictive' regulations governing direct-to-consumer advertising of pharmaceutical drugs; or Health Canada's first legislative review of the regulations since 1953.

It’s anybody’s guess which will arrive first: the golden anniversary of what some call the ‘ludicrous,’ ‘absurd,’ ‘bizarre’ and ‘severely restrictive’ regulations governing direct-to-consumer advertising of pharmaceutical drugs; or Health Canada’s first legislative review of the regulations since 1953.

The smart money seems to be on the former outcome, judging by Anne McLellan’s statement shortly after her appointment as federal health minister: ‘We have no intention of changing the present policy,’ she said to a scrum of reporters in March.

Yet Health Canada spokesman Ryan Baker told Strategy that ‘an LRP [legislative review process] is being finalized and the Department certainly hopes it will be completed soon, [after which] it will be presented to stakeholders and the public…to solicit feedback. Once all that is complete, we will determine when and how to present [new] legislation to Parliament for consideration.’

Stakeholders impatiently awaiting action from Health Canada basically fall into two camps.

Among those favouring an overhaul of the half-century-old regulations are mass media outlets eager to see prescription drug media buys shoot up by an estimated $200 million a year; marketers who want a better bang for their advertising bucks; and patients’ rights advocates running the gamut from the Canadian Association of Retired Persons to the Anemia Institute for Research and Education, all of which want consumers to have increased information about treatment options.

On the anti-relaxation side of the argument are major health insurance companies and large-scale employers who fear a flood of demands for expensive medications; plus various medical factions, such as the Canadian Medical Association, which almost seem to be contending that the doctor-knows-best situation of the 1950s is plenty good enough today (for more on the CMA’s stance, see ‘Leave the laws alone,’ p.18).

For the record, the peekaboo regulations, which are virtually unique in marketing’s modus operandi, offer advertisers two take-it-or-leave-it choices: One is to state the name of a drug but not reveal its purpose. The other is to discuss the disease or medical condition a drug addresses but not reveal the drug’s name. Combining the two halves of this informational equation is strictly a no-no.

The logic behind these now-you-see-it, now-you-don’t rules was most recently reiterated in a 1996 Health Canada policy paper explicitly prohibiting branded DTC drug advertising because its ‘primary aim [is] stimulating product sales’ – not simply advising consumers how to seek help for a given medical problem.

But isn’t following the rules akin to working in a straitjacket? ‘Categorically, yes,’ says Maxine Thomas, a strategic planner at Toronto’s Taxi, which created the most talked-about examples of the so-called ‘silent ads’ Ottawa dictates. They were, of course, for Pfizer Canada’s Viagra, a medication that combats erectile difficulties.

‘The usual way of communicating with target audiences is to create a motivating message that identifies a brand and cites its benefits,’ says Thomas. ‘But with prescription drugs, when we’re not allowed to tie the product benefits to the product name, it takes away one of the tools in our [creative] toolbox.’

Even minus that critical tool, the Taxi team came up with two effective campaigns for Viagra. One was last year’s TV spot, which kept the product name hush-hush and simply advised men with ED to level with their physicians about it. This was followed by the branded ‘Good Morning’ spot, which named Viagra and featured a euphoric dancing man, but left consumers to connect the dots between the two elements.

Last month, Taxi rolled out the first half of its second Viagra campaign, which is the ‘Straight Goods’ spot telling men not to merely blame themselves for having ED, but to explore possible physical causation with their doctors.

Although industry buzz maintained that Taxi’s first Viagra campaign flouted Health Canada’s regulations, Pfizer’s senior manager of corporate affairs Sylvie Letendre says it was, in fact, deemed to be ‘fully compliant.’

But Sandra Graham, senior VP of public affairs at the Ottawa-based Canadian Association of Broadcasters, says she and others in the pro-faction aren’t so sanguine about the Viagra campaign.

‘In fact, it really depicts the worst of the Canadian situation because Viagra is an important drug to help some people with a particular situation, but it’s also a dangerous drug if not taken properly. The ads that ran under the current regulations don’t say that. They simply rely on consumers already knowing about Viagra because of the spill from American advertising. If we’re really trying to give more information to Canadians, then let’s not just have a man skipping down the street saying it’s going to be a great day.’

Viagra’s high profile means its ads can afford to stick to the rules. But without that advantage, advertisers of other prescription drugs face a bigger challenge and sometimes resort to bolder efforts to push the DTCA envelope. Some of them – including Wyeth-Ayerst Canada’s Alesse birth control pills and GlaxoSmithKline’s Zyban smoking cessation aids – have been rapped on the knuckles by Health Canada for doing so.

Alesse’s transgression, in Ottawa’s view, was airing a branded ad and then, a few weeks later, a silent ad starring the same actors. Six months later, according to a recent article in the Canadian Medical Association Journal, Health Canada informed Wyeth-Ayerst that the campaign ‘is considered to contravene the Food and Drug Regulations.’ No penalty was imposed, but subsequent Alesse ads were unbranded.

GlaxoSmithKline (Glaxo Wellcome at the time) was notified, seven weeks after it ran what it considered an informational anti-smoking vignette featuring Zyban, that ‘These commercials violate section c.01.044(1) of the regulations. We ask you to immediately suspend broadcast of [them] until a full review of this activity can be completed.’

Health Canada’s Baker says that the investigation was ‘concluded to the Department’s satisfaction’ in December 2001.

But complying with both the letter and the spirit of the regulations, as GlaxoSmithKline does for its Heptopir hepatitis medication, can result in virtual anonymity, says Toronto-based Mark McElwain, VP of agency Allard Johnson’s wellness division. ‘These are pretty severe restrictions, especially for drugs that don’t have very high awareness among consumers.’

‘It’s totally absurd not to be able to share important information with people whose health is at risk,’ adds Mario Daigle, VP and GM, Wellness, at Allard Johnson’s Montreal office.

Susan Vogt agrees. ‘It’s just bizarre for advertisers to have to be this coy and not simply be free to tell their stories in a straightforward manner, as they do with other products.’ As a marketing and trademark lawyer at Toronto’s Gowling Lafleur Henderson, Vogt says she’s dealing with an increasingly frustrated array of clients who resent Health Canada for depriving Canada’s media of an estimated $200 million to $250 million per year.

That estimate on lost media dollars comes from the CAB’s Graham, and the irony of the situation, she says, is that Canadian consumers are already on the receiving end of massive drug advertising from both the Internet and the American media – especially since Washington greenlit drug advertising about five years ago.

‘DTCA is here and it’s increasing every day,’ Graham explains. ‘When we checked the January editions of the 10 American magazines most read by Canadians, for example, we counted 108 ads for prescription drugs.’

Why, in her opinion, is Ottawa dragging its legislative feet? ‘Back in 1953, the prevailing notion was that drugs were a bad thing that consumers had to be protected from. Medications to help with things like osteoporosis, asthma, hypertension and depression simply didn’t exist. That situation has changed dramatically in the last half century, but the regulations haven’t.’

Yet American DTCA is now so prevalent that Graham says even the 70 or so members of Parliament that the CAB has met with recently to discuss the regulations ‘weren’t aware that, one, the drug ads they’re seeing aren’t coming from Canadian companies; and, two, the claims about these medications aren’t regulated by any Canadian body. In fact, most of the MPs we talked to had no idea how the DTCA rules work in Canada or that they haven’t been updated in nearly 50 years.’

That obliviousness, says Terry Fallis, puts the legislators in the same category of ‘ludicrous mandated confusion’ as the average Canadians polled by Ipsos-Reid early this year at the request of the Alliance for Access to Medical Information (AAMI). Fallis is a spokesman for this coalition of stakeholders, which was founded in 1999 by members including CAB, the Canadian Newspaper Association, Magazines Canada and the Institute of Communications and Advertising (for more on the AAMI position, see ‘The regulations need reform,’ opposite).

A whopping 76% of respondents to AAMI’s poll agreed ‘that advertising about prescription medicines directly to consumers should be allowed’ by Canadian authorities. The number-one reason chosen for that response was the ‘consumer’s right to know’ about pharmaceutical options. ‘So the bottom line,’ says Fallis, ‘is that there is now a solid public policy basis for changing the rules.’

But what AAMI and other proponents of relaxed regulations don’t want, according to Graham and others, is the kind of free-for-all now prevailing south of the border. There, no regulatory body pre-approves drug advertising, although FDA regulations stipulate that all claims of efficacy must be accompanied by dire recitations of possible side effects.

‘We talk to doctors, nurses, hospital administrators, pharmacists, public health and patient groups. And overwhelmingly what we find is that no one thinks the American approach is anywhere near adequate,’ says Graham, noting particular exception to the absence of a U.S. board to pre-screen ads.

What the pro-relaxation faction here does want is multi-party development of what they call a ‘made-in-Canada model,’ explains Allard Johnson’s Daigle.

‘Absolutely no one is suggesting that the final gatekeepers for pharmaceutical medicines not be the doctors who write the prescriptions. But if patients are made aware of the available options, they can have informed discussions with those doctors. They can’t do that now because the average patient doesn’t have sufficient knowledge.’

And that, adds AAMI’s Fallis, is the built-in contradiction in Health Canada’s DTCA rules. ‘For the past 15 years, we’ve had the federal and provincial governments pushing Canadians to become more educated and more proactive consumers of health care, to become more active partners in the decisions that affect their health, and not to just let doctors tell them what to do. Putting blinders on Canadians is hardly the way to accomplish that.’

The made-in-Canada model envisioned by AAMI and others would include an official regulatory body, including representatives of government, medical experts and marketers, as the gatekeeper of drug advertising. Its role, says Graham would be to ‘pre-approve all drug advertising and make sure it is balanced and responsible and meets high standards.’

Of course, what Health Canada wants, or doesn’t want, will remain unknown until the results of its legislative review process are unveiled.

Meanwhile, says Toronto-based Sharon Gallant, EVP of Publicis Wellcare, ‘the Canadian public is being held hostage and put at risk. With science and medicine and pharmaceuticals moving at the speed of light, the DTCA regulations are antiquated at best and dangerous at worst. And unilingual francophones are being kept in the dark the worst because they’re not even getting American media messages about available treatment options.

‘We know that the appropriate use of medications saves lives, improves the quality of life and reduces health care costs because fewer people go to hospital when they take their drugs properly,’ Gallant continues. ‘So if we can’t disseminate appropriate health information to the public, Canadians are in serious trouble because they can’t make informed and appropriate choices.’